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Keeping It Simple - Implementing Pain Education for All

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
PNE4Adults
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
Eligible patients are; Danish speaking adult patients (≥18 years) Patients with chronic musculoskeletal pain (pain ≥ 3 months).

Sites / Locations

  • Køge Kommune

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

PNE4Adults

Arm Description

Participants will initially undergo 2 weeks of usual care.

Participants will undergo 2 sessions (1-2 weeks) where they will be introduced to the PNE4Adult board.

Outcomes

Primary Outcome Measures

Acceptability of the PNE4Adults
Acceptability of the combined intervention of PNE4Adults and usual care will be measured by a participant acceptability questionnaire on a 7-point Likert scale ranging from "very unacceptable", "unacceptable", "slightly unacceptable", "neither unacceptable nor acceptable", "slightly acceptable", "acceptable", and "very acceptable".
Comprehensibility of the PNE4Adults
How comprehensible the PNE4Adults is, will be measured by a participant questionnaire on a 7-point Likert scale ranging from "very incomprehensible", "comprehensible", "slightly incomprehensible", "neither incomprehensible nor comprehensible", "slightly comprehensible", "comprehensible", and "very comprehensible".

Secondary Outcome Measures

Concept of Pain Inventory (COPI-adult)
To assess adults' beliefs and knowledge of pain science, a Danish version of the Concept of Pain Inventory (COPI-adult) is used. It is a 13-item self-reported questionnaire with the following response options; "strongly disagree", "disagree", "unsure", "agree", "strongly agree".
Pain Self-Efficacy scale,
A questionnaire which measures how confident a person feels in dealing with everyday life despite having chronic pain. The PSEQ consists of 10 items, rated on a 7-point Likert scale ranging from 0 ("not confident at all") to 6 ("very confident").
Pain intensity
Pain intensity is assessed on Numeric Rating Scale (NRS) with answer options ranging from 0 = ("no pain") to 10 = ("worst imaginable pain"). We will collect average pain intensity last 24 hours (NRSavg), worst pain intensity last 24 hours (NRSmax) and current pain intensity (NRScur) as they all seem to convey different aspects of pain and together provide a more accurate measure of pain.
Pain Catastrophizing Scale
A questionnaire to assess catastrophizing in relation to actual or anticipated pain. The questionnaire has 3 sub-scales (i.e., rumination, magnification, and helplessness) and contains a total of 13-items. Patients use the same 5-point Likert-scale to respond to all 13 items ranging from "not at all" to "very much so"

Full Information

First Posted
November 6, 2021
Last Updated
May 5, 2022
Sponsor
Aalborg University
Collaborators
Municipality of Koege, Denmark, Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05140031
Brief Title
Keeping It Simple - Implementing Pain Education for All
Official Title
Keeping It Simple - Implementing Pain Education for All: a Clinical Cross-over Feasibility Study Among Chronic Pain Patients Referred to Community-based Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Municipality of Koege, Denmark, Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain education has proven difficult to implement into clinical practice. In Denmark 4 out of 10 adults has inadequate health literacy levels. To avoid inequality in health care we need a new and accurate method to provide pain education to all who need it. In this study, existing concept of pain education is implemented into clinical practice for a group of chronic pain patients including those with low degrees of health literacy, and then evaluate its use from both patient and physiotherapist perspective.
Detailed Description
The focus of this is project is to implement existing knowledge into clinical practice and to adapt and test a tool (i.e., PNE4Kids) that was initially developed to explain pain to children and their parents, for its potential to teach adults in pain about contemporary pain science in a way that takes into consideration those with low degrees of health literacy. Further, we want to test its feasibility in adult pain patients at a community-based rehabilitation center. It is expected that adult patients suffering from chronic pain will find the adapted PNE4Kids, named PNE4Adults, comprehendible, will benefit from this type of pain education in terms of increased pain knowledge and self-efficacy, and decreased pain-intensity and pain catastrophizing thoughts. It is also expected that physiotherapists will find the pain education program easy to engage with and to transfer into a clinical setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
After a period of "usual care" for 2-4 weeks, we want to cross-over and add the pain education intervention. The pain education intervention is an add-on to "usual care" and consists of an individualized pain education program in the form of Danish PNE4Adults. The education program consists of two session of +/- 1 hour each tailored individually to the needs of the patient. After the pain education, the patient will continue the planned rehabilitation program, but will integrate the knowledge obtained through the pain education, as an integrated part of the PNE4Adults program.
Masking
None (Open Label)
Masking Description
This study is designed as a cross-over study. As such, all participants will receive usual care before being introduced to the PNE4Adults board.
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Participants will initially undergo 2 weeks of usual care.
Arm Title
PNE4Adults
Arm Type
Experimental
Arm Description
Participants will undergo 2 sessions (1-2 weeks) where they will be introduced to the PNE4Adult board.
Intervention Type
Other
Intervention Name(s)
PNE4Adults
Intervention Description
It is a clear and concise program, that consists of a manual for the physiotherapist delivering the education and a board game to enhance engagement and participant involvement. It not only provides the physiotherapist with a clear "how-to" manual but also provides an easy and accessible way for the patient to grasp the difficult and complex concept of pain.
Primary Outcome Measure Information:
Title
Acceptability of the PNE4Adults
Description
Acceptability of the combined intervention of PNE4Adults and usual care will be measured by a participant acceptability questionnaire on a 7-point Likert scale ranging from "very unacceptable", "unacceptable", "slightly unacceptable", "neither unacceptable nor acceptable", "slightly acceptable", "acceptable", and "very acceptable".
Time Frame
During the final consultation, after approximeatly 6 weeks
Title
Comprehensibility of the PNE4Adults
Description
How comprehensible the PNE4Adults is, will be measured by a participant questionnaire on a 7-point Likert scale ranging from "very incomprehensible", "comprehensible", "slightly incomprehensible", "neither incomprehensible nor comprehensible", "slightly comprehensible", "comprehensible", and "very comprehensible".
Time Frame
During the final consultation, after approximeatly 6 weeks
Secondary Outcome Measure Information:
Title
Concept of Pain Inventory (COPI-adult)
Description
To assess adults' beliefs and knowledge of pain science, a Danish version of the Concept of Pain Inventory (COPI-adult) is used. It is a 13-item self-reported questionnaire with the following response options; "strongly disagree", "disagree", "unsure", "agree", "strongly agree".
Time Frame
T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care
Title
Pain Self-Efficacy scale,
Description
A questionnaire which measures how confident a person feels in dealing with everyday life despite having chronic pain. The PSEQ consists of 10 items, rated on a 7-point Likert scale ranging from 0 ("not confident at all") to 6 ("very confident").
Time Frame
T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care
Title
Pain intensity
Description
Pain intensity is assessed on Numeric Rating Scale (NRS) with answer options ranging from 0 = ("no pain") to 10 = ("worst imaginable pain"). We will collect average pain intensity last 24 hours (NRSavg), worst pain intensity last 24 hours (NRSmax) and current pain intensity (NRScur) as they all seem to convey different aspects of pain and together provide a more accurate measure of pain.
Time Frame
T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care
Title
Pain Catastrophizing Scale
Description
A questionnaire to assess catastrophizing in relation to actual or anticipated pain. The questionnaire has 3 sub-scales (i.e., rumination, magnification, and helplessness) and contains a total of 13-items. Patients use the same 5-point Likert-scale to respond to all 13 items ranging from "not at all" to "very much so"
Time Frame
T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligible patients are; Danish speaking adult patients (≥18 years) Patients with chronic musculoskeletal pain (pain ≥ 3 months).
Facility Information:
Facility Name
Køge Kommune
City
Køge
State/Province
Region Zeland
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Keeping It Simple - Implementing Pain Education for All

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